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Establishment Registration and Device Listing

Draft FDA Device Registrations in Minutes, Not Hours

12 minutes with CaseMark

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2. Upload the files you want analyzed.

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Workflow

Establishment Registration and Device Listing

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Workflow

Establishment Registration and Device Listing

Overview

Preparing FDA Establishment Registration and Device Listing documents manually requires hours of cross-referencing regulations, verifying classification codes, and ensuring compliance with 21 CFR Part 807. Attorneys must navigate complex FDA databases, validate product specifications against regulatory requirements, and format submissions according to strict agency standards—all while managing tight filing deadlines.

Preparing FDA Establishment Registration and Device Listing documents manually requires hours of cross-referencing regulations, verifying classification codes, and ensuring compliance with 21 CFR Part 807. Attorneys must navigate complex FDA databases, validate product specifications against regulatory requirements, and format submissions according to strict agency standards—all while managing tight filing deadlines.

CaseMark automates the entire FDA registration drafting process by intelligently extracting establishment and device information from your documents, cross-referencing current FDA regulations and classification databases, and generating compliant submissions formatted to agency standards. What once took half a day now takes minutes, with built-in verification against official FDA guidelines and templates.

How it works

  1. 1. Upload your documents

  2. 2. AI analyzes and extracts key information

  3. 3. Review and customize the generated content

  4. 4. Export in your preferred format (DOCX, PDF)

What you get

  • Document Header and Identification

  • Establishment Information

  • Owner/Operator Details

  • Device Listing

  • Compliance and Certifications

  • Signatures and Attestations

What it handles

  • Document Header and Identification

  • Establishment Information

  • Owner/Operator Details

  • Device Listing

  • Compliance and Certifications

  • Signatures and Attestations

Required documents

  • Establishment Information Records

    Company details including FEI number, business activities, owner information, and contact details

    .pdf, .docx, .txt

  • Device Specifications

    Product codes, classifications, intended use descriptions, and listing numbers for each device

    .pdf, .docx, .xlsx

Supporting documents

  • Previous FDA Submissions

    Prior registration forms or device listings for reference and consistency

    .pdf, .docx

  • U.S. Agent Information

    Details of U.S. agent if applicable for foreign establishments

    .pdf, .docx, .txt

  • Exemption Documentation

    Supporting materials for any claimed regulatory exemptions

    .pdf, .docx

Why teams use it

Generate compliant FDA registration documents in 12 minutes vs. 4.5 hours manually

Automatic cross-reference with 21 CFR Part 807 and current FDA classification databases

Built-in validation against official FDA Form 2830 requirements and templates

Intelligent extraction of establishment and device data from uploaded documents

Ensures compliance with latest FDA guidelines and regulatory best practices

Questions

How does CaseMark ensure FDA regulatory compliance?

CaseMark cross-references your submission against current 21 CFR Part 807 regulations and official FDA templates like Form 2830. The platform validates device classifications, verifies required fields, and formats documents according to FDA standards, ensuring your registration meets all regulatory requirements.

What documents do I need to prepare an FDA device listing?

You'll need establishment information (FEI number, business activities, owner details) and device specifications (product codes, classifications, intended use, listing numbers). CaseMark extracts this information from your uploaded documents and organizes it into the proper FDA format automatically.

How long does it take to draft FDA establishment registration documents?

Manual preparation typically takes 4-5 hours of attorney time to research regulations, verify classifications, and format submissions. CaseMark reduces this to approximately 12 minutes by automating data extraction, regulatory cross-referencing, and document generation.

Can CaseMark handle device classification and product codes?

Yes, CaseMark searches FDA device classification databases to verify product codes and classifications for your devices. The platform ensures each device listing includes accurate classification information and intended use descriptions that comply with FDA requirements.

Does the tool include U.S. agent information for foreign establishments?

Absolutely. CaseMark includes sections for U.S. agent details when applicable and incorporates any exemption documentation you provide. The platform ensures all compliance certifications and attestations meet FDA standards for both domestic and foreign establishments.

How does CaseMark verify establishment information accuracy?

CaseMark uses intelligent document extraction to pull establishment details from your uploaded files, then validates this information against FDA registration format requirements. The platform flags missing or incomplete data and ensures all owner/operator details, contact information, and FEI numbers are properly documented.

What happens after CaseMark generates my FDA registration document?

You receive a complete, formatted document ready for attorney review and submission to the FDA. The document includes all required sections—from establishment information to device listings to signature attestations—with proper citations to applicable regulations and compliance certifications.

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